GR1009925B - Cutting and angleing device for intraluminal navigation - Google Patents

Abstract

The present invention relates to an innovative vascular catheter (6) meant for the treatment of peculiar aortic aneurysms via the combinational ORSA & NICK technique. The catheter in question has the ability to angle the peripheral part (7) which bears a small piercing tool (13) or (14; furthermore, said catheter bears along its entire length distinct radiological contrast indicators. The usefulness of the NICK type intravascular catheter lies in the creation of a hole (9) inside an aortic endograft (8), in an X-ray environment 10 (ORSA & NICK technique). The main advantages are: i) Elimination of custom-made implants; 2) Minimization of the use of contrast fluid 15; iii) Increase of the survival of patients in rupture emergency (to date endovascular rehabilitation is impossible with the existing technology, while conventional surgery has survival rates of less than 20% worldwide); iv) Reduction of surgery costs by at least 50%.

Description

Description

Cutting and beveling device with intraluminal navigation

Technical field of the invention

The present invention relates to an innovative medical product (medical material), and more specifically to a novel intravascular catheter with a hydrophilic coating (6), which is specially designed, with specific characteristics for its placement in front of the bulging arterial branches- orifices (2) for the treatment of aortic aneurysms of particular morphology according to a newer surgical method.

Prior art level

Intravascular hydrophilic catheters are already known and widely used in peripheral vessels of the human body, as well as in coronary vessels of the heart. Their application is necessary during endovascular interventions (e.g. coronary angiography, etc.), for the passage of wires, air chambers, stents and a multitude of other devices and substances through them.

Currently, endovascular repair of pararenal, suprarenal, thoracoabdominal aortic aneurysms as well as subrenal, small or negligible neck, aneurysms is extremely difficult for the vascular surgeon, and the majority of cases require a specially shaped graft (fenestrated graft) and current OL "chimney", "sandwich" and "periscope" techniques used are not without complications, with the clinician having to convert the restoration to an open one, if not to re-intervene on the same patient several times.

It is noted that with modern technology the endovascular treatment of aortic aneurysms of a special type is extremely time-consuming, it is based on custom-made grafts that require waiting several months for their manufacture, and the procedure is extremely difficult, requiring experience that a vascular surgeon can rarely acquire and in in many cases it can lead to serious complications, most notably acute kidney failure due to the use of large amounts of contrast agents (toxic to the kidneys), the need for reoperation, and even death. From the above it can be understood that in emergency situations, such as aneurysm rupture, newer techniques are of little help given the time required to manufacture these custom-made grafts. By special type aortic aneurysms are meant those aneurysms where, due to characteristic morphologies, they cannot be treated endovascularly with the use of ready-made standardized endografts that are usually found in the inventory of every vascular surgery clinic. The special type of aneurysms are mostly referred to infrarenal aneurysms with little or no neck, pararenal, suprarenal, thoracoabdominal and aortic arch aneurysms. They concern the minority of aneurysms that are treated daily by the surgeon, however to this day they are extremely deadly.

Summary of the invention

Considering the state of the art, related custom implants and their disadvantages, there is described, as an embodiment of the present invention, a novel endovascular, hydrophilic-coated catheter (6), the use of which is fundamental importance for the application of an innovative methodology of surgical repair of a specific type of aortic aneurysms (ORSA & NICK technique) through the combined oral placement of metal stents (O.R.S.A.) and cutting and angulation through intraluminal navigation (N.I.C.K.).

The innovative NICK-type endovascular catheter (6) has the ability to pass through the aorta and arteries and the ability to angle (7) its front part (tip) to the right and left. Inside it has an independent catheter of smaller diameter which is completely hidden inside the first one and, at will, can be brought out in relation to the first one from its anterior part (tip). It carries at the perforated end of the small nisson tool (13) or (14) which is attached to the end of the inner probe, which has the possibility of rotation along the longitudinal axis inside the outer probe, manually or by means of a low-speed electric motor (motor) . It also carries, throughout its length, distinct non-opaque indicators, making it radiopaque throughout its length.

Although surgical procedures are expressly excluded from patentability, the present application includes a detailed description of the novel ORSA & NICK technique since the embodiment of the present invention does not refer to an improved catheter compared to existing commercially available ones. The intravascular NICK type catheter (6) has a completely different, innovative use and although its usual application is necessary during the ORSA & NICK technique (for the passage of wires, stents, etc.), the usefulness of its innovative features lies in its precise placement within the coated aortic stent (8), due to the clearly visible radiopaque markers (4), and mainly in the creation of a hole (9) within this aortic stent, in a fluoroscopy environment, with the ultimate aim of endovascular treatment of aortic aneurysms of a special type. For the above reason, the detailed description of the innovative ORSA & NICK technique, although expressly outside the scope of patenting, is an integral part of this application, where the use of the NICK endovascular catheter (6) is analyzed in the various stages of the technique , its importance in the technique as well as a detailed and comprehensible explanation of the technique in question.

The application of the described embodiment of the present invention results in the possibility of restoring demanding aneurysms without the need for a special order and custom-made manufacture of grafts from abroad, which is particularly time-consuming and in many cases, especially in emergency situations, makes the treatment unfeasible, while the complications of any other therapeutic intervention are fatal in more than 50% of these cases.

Brief description of actions

In order to understand in detail the manner in which the above features, aspects, and advantages of the invention are achieved, as well as what else becomes apparent, a more specific description of the invention summarized above, and illustrated in Figures 1 through 21, is provided. which form part of this detailed report. It should be noted, however, that the Figures illustrate only one embodiment of the invention and its possibilities of use and should not be considered as limiting the scope of the invention, because the invention may lead to other equally effective embodiments.

Figure 1: Schematic representation of the NICK-type endovascular catheter (6). A perforated scalpel (13 Figure 1a) or drill (14 Figure 1b) is inserted through the NICK type endovascular catheter in order to make a hole (9) in the fabric wall of the aortic stent (8) and pass the guide wire (5) into of an oral stent (1) already deployed in the target artery (e.g. renal artery).

Figure 2: Deployment of a stomatal stent (1) to the bulging (stoma) of the arterial branches (2) precedes the main surgical procedure to repair the aneurysm.

Figure 3: Patient preparation is completed by deploying the oral stent (1). Any aneurysm repair intervention is now possible. Figure 4: Catheterization of the femoral arteries to achieve placement of the stomatal stent (1) of the sphincter-stomach, a (2) of the renal (15) and superior mesenteric artery (16).

Figure 5: Insertion of a NICK-type endovascular catheter (6) into the main body of the aortic endograft (8) with the help of a guide wire (5).

Figure 6: Introduction of NICK-type endovascular catheter (6). The bending of (7) takes place in the sealing zone of the endograft, i.e. at the height where the stoma (1) has been placed. In a fluoroscopy environment, navigation is done exclusively by the non-obscuring markers (4) of the stent (1).

Figure 7: Perspective view of the main body of the aortic graft (8). The radiopaque markers (4) of the ostial stent (1) marking the ostium of the target artery (2) are observed.

Figure 8: The guide wire (5) of the NICK type endovascular catheter (6) has been lowered. in the aortic stent (8).

Figure 9: The placement of the NICK-type endovascular catheter (6) through the guidance of the radiopaque markers (4) of the oral stent (1). A horizontal rotation to the left is necessary to achieve alignment with the ostium of the target artery (figure 9a). A correct alignment has been achieved (figure 9b). The operation can proceed by cutting the fabric of the aortic stent

(8).

Figure 10: View from the inside of the aortic stent (8) at the level of the sealing zone area. The proximal part of the stomatal stent (1) and the radiopaque markers (4) around the mouth of the aortic branch artery (2) are seen behind the stent (8).

Figure 11: Accurate placement of the NICK-type endovascular catheter (6) with the help of the radiopaque markers (4) of the oral stent (1).

Figure 12: The surgeon can now proceed to puncture the fabric wall of the aortic stent (8) with the help of the NICK endovascular catheter (6) and insert a guide wire (5) into the artery through the stomatal stent (1) ).

Figure 13: The wire (5) is now inside the ostium of the target artery (2).

Figure 14: Successful insertion of the hydrophilic wire (5) into the distal part of the target artery.

Figure 15: Insertion and completion of deployment of the coated stent (12). Figure 16: Adequate organ perfusion is achieved through residual endoleak (arrows indicating blood flow) from the ipsilateral (10) but mainly the contralateral (11) leg of the aortic endograft (8).

Figure 17: View of the hole (9) after the removal of the NICK-type endovascular catheter (6), on the fabric of the aortic stent (8). Note that the view is from the inside of the aortic stent (8).

Figure 18: The NICK endovascular catheter (6) has just made a hole (9) in the endograft fabric (8).

Figure 19: A hydrophilic guidewire (5) is passed into the target artery through the hole (9) and guided by the radiopaque markers (4) of the oral stent (1).

Figure 20: A coated stent (12) is now inserted through the previously opened passageway into the target artery (2) - branch of the aorta - via the NICK endovascular catheter (6).

Figure 21: Final stage of the operation. Full deployment of the coated splint (12). Reperfusion of the branch artery of the aorta after temporary interruption due to expansion of the aortic endograft (8). Blood flow is now from the aortic graft (8) to the aortic branch artery through the coated stent (12).

Detailed description of the invention

As a main embodiment of the invention, an intravascular catheter with a hydrophilic coating (6, Figure 1) is described. It is characterized by the possibility of passing inside the aorta and arteries through a guide wire (5), up to 0.35 inch and the possibility of angulation of its front part (tip) up to 90 degrees (7) right and left (total angulation range 180 degrees) . Inside it has an independent catheter of smaller diameter which is completely hidden inside the first one and, at will, it can come out in relation to the first one from its anterior part (tip). It carries a small tool (13) or a drill (14) made of metal or synthetic biocompatible material at the perforated end of its handle. Both the drill (14) and the nisson tool (13) are attached to the end of the inner probe, which is rotatable about the longitudinal axis within the outer probe, manually or by means of a low-speed electric motor (motor). It carries along its entire length distinct ray-dark markers. The above construction during its application offers satisfactory bending and excellent resistance to fatigue.

The NICK-type endovascular catheter (6) is a specially designed invention for its precise placement within a coated aortic stent (8), and mainly for the creation of a hole (9) within this aortic stent, in a fluoroscopy environment, with the ultimate aim of endovascular, acute treatment of aortic aneurysms of particular morphology according to a novel technique (ORSA & NICK) which is described in detail below.

The ORSA & NICK technique initially involves marking the major orifices of the aortic branch-arteries by means of a stomatal stent (1 Figure 2) and is performed at the same time or before the main operation of aneurysm repair. Arterial access-catheterization involves even small vessels, such as the carotid artery, and, like the deployment of stents, the need for an iodinated contrast and imaging machine (C-arm) is mandatory in every case.

In terms of patient preparation, there is no difference compared to a simple conventional digital subtraction angiography (DSA) or angioplasty (PTA) procedure. Complete deployment of the oral stent (1) indicates the end of the pre-surgical ORSA procedure (Figure 3). Suggested. mainly the catheterization of the femoral arteries or the femoral, brachial, axillary arteries on indications (Figure 4).

After deployment of the metal stents (1), it is time for the main operation, based on the classical procedure for EVAR (EndoVascular Aneurysm Repair): Expansion of the main body into the aorta (8), contralateral (11) and the ipsilateral (10) iliac extension, according to the type of endograft we use. The difference is that sometimes due to the type of aneurysm, e.g. suprarenal, expansion must be performed over the renal arteries. In this case, OL kidneys and other organs of the abdomen or chest will stop receiving blood and will begin to become ischemic. The main point at this stage of the process is the restoration of blood flow to your arteries that supply these organs.

For this reason it is necessary to use the cutting and angling device with intraluminal navigation (endovascular catheter type NICK 6) which is a variant of the widely used endovascular catheters (Figures 5-6). This device has the ability to bend and angle (7) depending on the angles to be achieved (usually around 90 degrees), but mainly it has the ability to create a hole (9) in the main body of the endograft (8) ( Figure 1). The latter is necessary to create a passageway for the coated metal stent (12) delivery device as well as to introduce it into the target arterial branch, e.g. renal artery (15). The guidance of the NICK-type endovascular catheter (6) is based on the radiopaque markers that include the oral stent (1), which also includes radiopaque markers (4), which guide the endovascular catheter in the middle of the mouth (vertically and horizontally), without the use of a contrast medium (Figures 7-9). In general, with this methodology the use of any contrast agent will be minimized, since the pre-deployment of the stomatal stent (1) gives accurate information about the position of the arterial orifice (2) and an alignment of the NICK endovascular catheter. (6) is quite easy for the surgeon (Figures 10-15) to place the endograft. Any contrast agent that will be needed in the operation is mainly for the final angiography, rather than for the aforementioned procedure, which will be performed under the guidance of radiopaque markers (4).

Regarding the time that the organs will take part in the procedure and remain in ischemia, according to the literature, there is enough time for the procedure to be completed, while at the same time, due to the partial expansion of the aortic graft (8), enough blood will be supplied to the organs through the temporary endoleak of the ipsilateral (10) and mainly the contralateral leg (11) of the main body of the aortic graft (Figure 16).

Summarizing all of the above (Figures 17-21), the procedure will end with deployment of the contralateral (11) and (in some types of grafts) the ipsilateral (10) extension of the aortic graft, which is not the subject of the present invention. Final angiography will be performed to demonstrate a satisfactory post-operative outcome before the surgeon decides whether or not to complete the operation. A typical, but not unique, example of application is the thoracoabdominal aortic aneurysm type IV (the dilatation of the aorta involves the entire part below the diaphragm). In figures: figure 3, figure 4, figure 5, figure 6, figure 18, figure 19, figure 20 and figure 21, a simplified image of a type IV thoracoabdominal aneurysm is provided for the sake of understanding. Non-important aortic branches have been removed. The course of the operation is described schematically with the placement of the special stents (1) and the aortic endograft (8) and then the connection-perfusion process of the right renal artery (15) with the aortic endograft (8) through a coated stent ( 12), utilizing the devices and techniques O.R.S.A and N.I.C.K.

Advantages of the invention

The main advantages of the NICK type endovascular catheter (6) disclosed in the present application, compared to other described methods and technologies, are summarized as follows:

i) Eliminates the need for custom-made grafts.

ii) Keeps the use of contrast fluid to a minimum.

iii) It increases the survival expectancy in a where until now with the existing one it is unattainable, while the open, lower class of the order of 20% worldwide iv) It reduces the cost of the operation for patients in the emergency state of rupture, technology endovascular reconstructive surgery has survival rates s.

histone by 50%.

Claims (13)

Cutting and beveling device with intraluminal navigation Claims What is claimed is: 1. Cutting and angling system with intraluminal navigation capability (6) with the following characteristics: External, hydrophilic, flexible, endovascular, even catheter with the possibility of entering the aorta and arteries and the ability to angulate right and left. It has a wide lumen along its entire length. It carries inside the second flexible catheter with the possibility of a guide wire as well, which has a nisson tool attached to its peripheral end and has the ability to rotate freely inside the external catheter. It carries along radiopaque markers, so that the device is sharp in a fluoroscopy environment. 2. Apparatus according to claim 1, characterized by guidewire capability of up to 0.035 inch. 3. Device according to claim 1, characterized by the possibility of angling (7) up to 90 degrees to the right and left, so that the total range of angulation reaches 180 degrees. Apparatus according to claim 1, whose main tool can be a scalpel (13) or a drill (14). 5. Device according to claim 1, characterized in that it is made of biocompatible, synthetic hydrophilic material, except for the angulation-navigation mechanism and the floating tool that it may consist of. from synthetic or metal biocompatible material, so that during its application it offers satisfactory, bending, perfect fit to the anatomy of the vessel and excellent resistance to fatigue. 6. Device according to claim 1, characterized by the fact that it is specially designed for its navigation in bulging arterial branches (2) -stomas- for the treatment of particular morphology of aortic aneurysms. 7. Device according to claim 1, characterized in that, the diameter of the outer catheter does not exceed 6 millimeters (18F), the diameter of the inner catheter does not exceed 5 millimeters (15F), the length of the outer starts from 40 centimeters and reaches up to 120 cm and the length of the interior starts from 60 cm and reaches 140 cm. 8. Device according to claim 1, characterized in that the free end of the external catheter can be bent with the help of special wires inside the wall of the catheter and mechanism. 9. Device according to claim 1, characterized in that its free end can be bent up to 90 degrees by construction and is transported. in a straight position through an expander which retracts. when the probe is placed on the target point giving it its normal vertical form. 10. Device according to claim 1, characterized in that, the nisson tool can have a special synthetic or metal cover during its transport inside the external catheter, in order to ensure safe advancement to the arterial target, with the possibility of uncovering, through manual or electrical mechanism, on the point of its application to the fabric wall of the coated aortic endograft (8). 11. Device according to claim 1, characterized in that, the nisson tool is inseparably attached to the free end of the internal catheter, with an extremely durable connection, so that it can follow the rotational movements during the intervention by the interventional physician. 12. A device according to claim 1, characterized in that the proximal end of the inner catheter can be connected to a low-speed electric motor or torque arms for electrically or manually rotating the carrying tool to create a hole in the tissue of the endograft (8). 13. Device according to claim 1, characterized in that it can enter. into the arteries and aorta through sheaths (special endovascular disposable devices) with a maximum internal diameter of 6 millimeters (18 F).